Psoriasis-Arthritis & Bone Program

NCT02483234 | Completed Phase 2

• 1 other identifier: CAIN457F2301T
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Purpose and rationale: To define the role of IL-17 as a mediator of structural bone lesions in psoriasis patients and patients with PsA. Primary Objective is the improvement of the PsAMRIS synovitis score baseline vs. week 24. Drug tested is Secukinumab 300 mg administered weekly for 4 weeks, then 4 weekly s.c. with a duration total of 24 weeks. Indication for this study is Psoriasis (Pso) and psoriatic arthritis (PsA).

Conditions

Psoriasis; Psoriatic Arthritis

Outcome Measures

Primary Outcomes (1)

• The improvement of the PsAMRIS synovitis score

  baseline to week 24

Study Arms (1)

Psoriasis/Psoriatic arthritis

EXPERIMENTAL

Patients with Psoriasis and inflammatory and/or structural lesions and/or erosions in the MRI/HR-qCT scan will be treated with Secukinumab. Patients with psoriatic arthritis will be treated with Secukinumab. Bone changes will be evaluated influenced by IL-17 blockade

Drug: secukinumab

Interventions

secukinumab DRUG

Psoriasis/Psoriatic arthritis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects taking DMARDs (e.g. MTX) are allowed to continue their medication if the dose is stable for at least 4 weeks before baseline and should remain on a stable dose up to Week 24.
• Subjects who have previously been treated with TNFα inhibitors (investigational or approved) will be allowed entry into study after appropriate wash-out period prior to randomization
• PsA patients:
• Diagnosis of PsA classified by CASPAR criteria and with symptoms for at least 6 months with moderate to severe PsA who must have at Baseline ≥3 tender joints out of 78 and ≥3 swollen out of 76 (dactylitis of a digit counts as one joint each)
• Rheumatoid factor and anti-CCP antibodies negative at screening
• Subjects with PsA should have taken NSAIDs for at least 4 weeks prior to randomization with inadequate control of symptoms or at least one dose if stopped due to intolerance to NSAIDs
• Subjects taking corticosteroids must be on a stable dose of ≤10 mg/day prednisone or equivalent for at least 2 weeks before baseline and should remain on a stable dose up to Week 24
• Psoriasis patients:
• moderate-to severe psoriasis (PASI \> 6)
• no diagnosis of PsA
• inflammatory and/or structural lesions and/or erosions in the MRI/HR-qCT scan

You may not qualify if:

• Chest X-ray or chest MRI with evidence of ongoing infectious or malignant process, obtained within 3 months prior to screening and evaluated by a qualified physician
• Subjects taking high potency opioid analgesics (e.g. methadone, hydromorphone, morphine)
• Previous exposure to secukinumab or other biologic drug directly targeting IL-17 or IL-17 receptor
• Ongoing use of prohibited psoriasis treatments / medications (e.g., topical corticosteroids, UV therapy) at baseline. The following wash out periods need to be observed:
• Oral or topical retinoids 4 weeks
• Photochemotherapy (e.g. PUVA) 4 weeks
• Phototherapy (UVA or UVB) 2 weeks
• Topical skin treatments (except in face, scalp and genital area during screening, only corticosteroids with mild to moderate potency) 2 weeks
• Subjects who have ever received biologic immunomodulating agents except for those targeting TNFα or IL-23p40, investigational or approved
• Previous treatment with any cell-depleting therapies including but not limited to anti-CD20, investigational agents (e.g., CAMPATH, anti-CD4, anti-CD5, anti-CD3, anti-CD19)
• Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unwilling to use effective contraception during the study and for a minimum of 20 weeks after stopping treatment. Effective contraception is defined as either:
• Barrier method: Condom or Occlusive cap (diaphragm or cervical/vault caps) with spermicide (where available). Spermicides alone are not a barrier method of contraception and should not be used alone
• The following methods are considered more effective than the barrier method and are also acceptable:
• Total abstinence: When this is in line with the preferred and usual lifestyle of the subject \[Periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception\]
• Female sterilization: have had a surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least six weeks before taking study treatment. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment

Sponsors & Collaborators

• University of Erlangen-Nürnberg Medical School: lead

Study Sites (1)

University of Erlangen-Nuremberg

Erlangen, 91054, Germany

Location

Related Publications (3)

• Kampylafka E, Tascilar K, Lerchen V, Linz C, Sokolova M, Zekovic A, Kleyer A, Simon D, Rech J, Sticherling M, Schett G, Hueber AJ. Secukinumab leads to shifts from stage-based towards response-based disease clusters-comparative data from very early and established psoriatic arthritis. Arthritis Res Ther. 2020 Sep 9;22(1):207. doi: 10.1186/s13075-020-02268-y.

  PMID: 32907626 DERIVED

• Kampylafka E, Simon D, d'Oliveira I, Linz C, Lerchen V, Englbrecht M, Rech J, Kleyer A, Sticherling M, Schett G, Hueber AJ. Disease interception with interleukin-17 inhibition in high-risk psoriasis patients with subclinical joint inflammation-data from the prospective IVEPSA study. Arthritis Res Ther. 2019 Jul 26;21(1):178. doi: 10.1186/s13075-019-1957-0.

  PMID: 31349876 DERIVED

• Kampylafka E, d'Oliveira I, Linz C, Lerchen V, Stemmler F, Simon D, Englbrecht M, Sticherling M, Rech J, Kleyer A, Schett G, Hueber AJ. Resolution of synovitis and arrest of catabolic and anabolic bone changes in patients with psoriatic arthritis by IL-17A blockade with secukinumab: results from the prospective PSARTROS study. Arthritis Res Ther. 2018 Jul 27;20(1):153. doi: 10.1186/s13075-018-1653-5.

  PMID: 30053825 DERIVED

MeSH Terms

Conditions

Psoriasis; Arthritis, Psoriatic

Interventions

secukinumab

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2015
• First Posted: June 26, 2015
• Study Start: May 31, 2015
• Primary Completion: June 30, 2018
• Study Completion: September 30, 2018
• Last Updated: September 27, 2019

Record last verified: 2019-09

Locations

DE (1)